Nucleus Cochlear Implant Systems

FDA Premarket Approval P890027 S062

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

DeviceNucleus Cochlear Implant Systems
Generic NameImplant, Cochlear
ApplicantCochlear Americas13059 E Peakview Avecentennial, CO 80111 PMA NumberP890027 Supplement NumberS062 Date Received04/26/2022 Decision Date10/31/2022 Product Code MCM  Advisory Committee Ear Nose & Throat Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
Date Received2022-04-26
Decision Date2022-10-31
PMAP890027
SupplementS062
Product CodeMCM 
Advisory CommitteeEar Nose & Throat
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination ProductNo
Applicant AddressCochlear Americas
13059 E Peakview Ave
centennial, CO 80111 PMA NumberP890027 Supplement NumberS062 Date Received04/26/2022 Decision Date10/31/2022 Product Code MCM  Advisory Committee Ear Nose & Throat Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement  
for A New Sound Processor (Nucleus 8 Sound Processor) And Two Supporting Software Devices (Custom Sound Pro And Nucleus Smart App)

Supplemental Filings

Supplement NumberDateSupplement Type
P890027Original Filing
S062 2022-04-26 Normal 180 Day Track
S061
S060 2019-08-15 Normal 180 Day Track
S059 2017-05-23 Normal 180 Day Track
S058 2017-02-09 Special (immediate Track)
S057 2009-10-13 Special (immediate Track)
S056 2007-09-14 Real-time Process
S055 2002-12-16 Real-time Process
S054 2002-12-06 Normal 180 Day Track
S053 2002-10-31 Normal 180 Day Track
S052 2002-08-28 Special (immediate Track)
S051 2001-09-28 Normal 180 Day Track
S050 2001-04-19 Normal 180 Day Track
S049 2000-11-29 Normal 180 Day Track
S048 1999-10-20 Real-time Process
S047 1999-04-15 30-day Notice
S046 1998-09-21 Real-time Process
S045 1998-08-17 Normal 180 Day Track
S044 1998-03-18 30-day Notice
S043 1998-02-09 Special (immediate Track)
S042 1997-12-09 Normal 180 Day Track
S041 1997-10-02 Normal 180 Day Track
S040 1997-09-25 Normal 180 Day Track
S039 1997-07-01 Normal 180 Day Track
S038 1997-04-24 Normal 180 Day Track
S037 1997-02-18 Normal 180 Day Track
S036 1996-08-07 Normal 180 Day Track
S035 1996-06-20 Normal 180 Day Track
S034 1996-06-06 Normal 180 Day Track
S033 1996-05-06 Normal 180 Day Track
S032 1996-04-25 Special (immediate Track)
S031 1996-04-24 Normal 180 Day Track
S030 1996-02-23 Normal 180 Day Track
S029 1995-11-24 Normal 180 Day Track
S028 1995-10-31 Normal 180 Day Track
S027 1995-03-03 Normal 180 Day Track
S026 1995-02-28 Normal 180 Day Track
S025 1994-10-04 Normal 180 Day Track
S024
S023 1994-05-27 Normal 180 Day Track
S022 1994-05-06 Normal 180 Day Track
S021 1993-09-30 Normal 180 Day Track
S020 1993-09-01 Normal 180 Day Track
S019 1993-07-07 Normal 180 Day Track
S018 1993-06-03 Normal 180 Day Track
S017 1992-09-08 Normal 180 Day Track
S016 1992-08-13 Normal 180 Day Track
S015 1992-07-23 Normal 180 Day Track
S014 1992-04-09 Normal 180 Day Track
S013 1992-04-09 Normal 180 Day Track
S012 1992-02-06 Normal 180 Day Track
S011 1992-02-06 Normal 180 Day Track
S010 1992-01-21 Normal 180 Day Track
S009 1992-01-13 Normal 180 Day Track
S008 1991-12-24 Normal 180 Day Track
S007 1991-11-15 Normal 180 Day Track
S006 1991-09-20 Normal 180 Day Track
S005 1991-08-22 Normal 180 Day Track
S004 1991-05-31 Normal 180 Day Track
S003 1991-03-27 Normal 180 Day Track
S002 1991-02-28 Normal 180 Day Track
S001 1991-01-08 Normal 180 Day Track

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